SARS-CoV2 InfectionSubFSC19-KNNCT04883190
Fatigue a Long COVID-19 Symptom Substudy of FSC19-KN Trial
An observational study of SARS-CoV2 Infection, run by Hegau-Bodensee-Klinikum Singen at 1 site in Germany.
Trial summary
Prospective, controlled follow-up observation of SARS-CoV-2 positive patients with regard to the aspect of fatigue (cognitive / motor) and psychological disorders in the areas of anxiety, depression and somatization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- Fulfilling Questionaires
- How many people
- 353 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2021to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Within the FSC19-KN trial up to 250 SARS-CoV-2 positive patients and 250 volunteers without SARS-CoV-2 infection are included. We plan to contact all attendees of the FSC19-KN trial which gave permission to contact via e-mail. They will be asked to contribute the sub-study by declaring their informed consent online. Only if their agreement of participation is given, they can fill in our online questionnaire.
Who may be able to join
- Patient must meet ALL of the following criteria.
- Participation in the FSC19-KN study
- Consent to participate in the survey
Who cannot join
- 1. Failure to give consent to the survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical and Mental Fatigue a Long COVID-19 Symptom - Substudy of FSC19-KN Trial
Prospective, controlled follow-up observation of SARS-CoV-2 positive patients with regard to the aspect of fatigue (cognitive / motor) and psychological disorders in the areas of anxiety, depression and somatization.
Read the detailed description
After informed consent is given, questionnaires will be obtained 6 months and 12 months after infection. For analyzing cognitive and motor fatigue, classified in mildly, moderately or severely fatigue the questionnaire will be calculated by The Fatigue Scale for Motor and Cognitive Functions (FSMC).
And the occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome measured by Brief Patient Health Questionnaire.
The FSC19-KN trial already included patients with positive test for SARS-CoV-2 by PCR and volunteers with negative SARS-CoV-2 antibody testing. Verification of exclusion criteria had been completed in the main trial FSC19-KN. After the informed consent to participation in the sub-study is given all inclusion modalities are fulfilled.
- Conditions
- SARS-CoV2 Infection
- Being tested
- Fulfilling Questionaires
- Keywords
- Fatigue, Covid-19 Disease
- Medical subject headings
- COVID-19, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fulfilling QuestionairesOther
Fulfilling Questionaires PHQ-D (brief) and FSMC
| Study group | Role | What they receive |
|---|---|---|
| 1. after SARS-CoV-2 infection | All participants in the study and control group of the FSC19-KN study will be contacted either by email or by post.
We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group. Receives: Other: Fulfilling Questionaires | |
| 2. control group with negative antibody test | All participants in the study and control group of the FSC19-KN study will be contacted either by email or by post.
We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group. Receives: Other: Fulfilling Questionaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of fatigue
Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue
Measured: 6 month after infection
Presence of fatigue
Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue
Measured: 12 month after infection
Secondary outcomes (2)
Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.
analyzed by PHQ-D (brief)
Measured: 6 month after infection
Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.
analyzed by PHQ-D (brief)
Measured: 12 month after infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start15 May 2021
- Primary completion1 Jun 2022
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hegau-Bodensee-Klinikum Singen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Kollum, PD Dr., Principal investigator, Hegau-Bodensee-Klinikum Singen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883190
- Sponsor's protocol ID
- 21-1340
- Acronym
- SubFSC19-KN
- Status last verified
- Feb 2024
- First submitted
- 30 Apr 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The aim is to publish the results in a peer reviewed medical journal without sharing any participant data
Publications
Sabrina Geng, Jonas Haberland, Elisabeth Haberland, Julia Hromek, Heidi Zimmermann, et al, (2024), Effects on Fatigue and Depression 11 And 19 Months after a Sars-Cov-2 Infection a Case Control Study, J. Clinical Cardiology and Cardiovascular Interventions, 7(2); DOI:10.31579/2641-0419/348
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Mental Fatigue a Long COVID-19 Symptom - Substudy of FSC19-KN Trial
- ClinicalTrials.gov ID
- NCT04883190
- Acronym / sponsor ID
- SubFSC19-KN / 21-1340
- Conditions
- SARS-CoV2 Infection
- Keywords
- Fatigue, Covid-19 Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Hegau-Bodensee-Klinikum SingenUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, controlled follow-up observation of SARS-CoV-2 positive patients with regard to the aspect of fatigue (cognitive / motor) and psychological disorders in the areas of anxiety, depression and somatization.
Detailed description
After informed consent is given, questionnaires will be obtained 6 months and 12 months after infection. For analyzing cognitive and motor fatigue, classified in mildly, moderately or severely fatigue the questionnaire will be calculated by The Fatigue Scale for Motor and Cognitive Functions (FSMC).
And the occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome measured by Brief Patient Health Questionnaire.
The FSC19-KN trial already included patients with positive test for SARS-CoV-2 by PCR and volunteers with negative SARS-CoV-2 antibody testing. Verification of exclusion criteria had been completed in the main trial FSC19-KN. After the informed consent to participation in the sub-study is given all inclusion modalities are fulfilled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. after SARS-CoV-2 infection | – | Other: Fulfilling QuestionairesAll participants in the study and control group of the FSC19-KN study will be contacted either by email or by post. We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group. |
| 2. control group with negative antibody test | – | Other: Fulfilling QuestionairesAll participants in the study and control group of the FSC19-KN study will be contacted either by email or by post. We plan to write to around 200-250 patients after SARS-CoV-2 infection and 200-250 test subjects in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Within the FSC19-KN trial up to 250 SARS-CoV-2 positive patients and 250 volunteers without SARS-CoV-2 infection are included. We plan to contact all attendees of the FSC19-KN trial which gave permission to contact via e-mail. They will be asked to contribute the sub-study by declaring their informed consent online. Only if their agreement of participation is given, they can fill in our online questionnaire.
Key inclusion criteria (3 listed)
- Patient must meet ALL of the following criteria.
- Participation in the FSC19-KN study
- Consent to participate in the survey
Key exclusion criteria (1 listed)
- 1. Failure to give consent to the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fulfilling QuestionairesFulfilling Questionaires PHQ-D (brief) and FSMC | Other | 1. after SARS-CoV-2 infection, 2. control group with negative antibody test |
Primary outcome
Presence of fatigue
Time frame: 6 month after infection
Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue
Presence of fatigue
Time frame: 12 month after infection
Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue
2 secondary outcomes
Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.
Time frame: 6 month after infection
Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.
Time frame: 12 month after infection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Results publicationSabrina Geng, Jonas Haberland, Elisabeth Haberland, Julia Hromek, Heidi Zimmermann, et al, (2024), Effects on Fatigue and Depression 11 And 19 Months after a Sars-Cov-2 Infection a Case Control Study, J. Clinical Cardiology and Cardiovascular Interventions, 7(2); DOI:10.31579/2641-0419/348
- Individual participant dataSharing planned: No. The aim is to publish the results in a peer reviewed medical journal without sharing any participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Kollum, PD Dr. principal investigator
Hegau-Bodensee-Klinikum Singen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2 Infection, run by Hegau-Bodensee-Klinikum Singen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of fatigue (time frame: 6 month after infection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04883190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.